A phase III trial investigating the efficacy and safety of Grazax in children aged 5-16 years with grass pollen induced rhinoconjunctivitis with or without asthma

• Conditions: IgE Mediated allergy (hay fever, rhinoconjunctivitis) to grass pollen (Timothy grass, Phleum pratense) with or without asthma

• Registration Number: EUCTR2006-003415-46-DE
• Lead Sponsor: ALK-Abello, Group Clinical Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-25
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•To investigate the efficacy and safety of Grazax based on the following information:
?Rhinoconjunctivitis symptom and medication scores in the peak grass pollen season
?Asthma symptom and medication score in the grass pollen season
?Asthma symptom and medication score in the peak grass pollen season
?Pharmacoeconomic data in the grass pollen season
?Safety Assessments at screening and End of treatment

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria
1.Current food allergies with oral allergy syndrome
2.A clinical history of symptomatic seasonal allergic rhinitis and/or asthma having received regular medication due to another allergen during – or potentially overlapping - the grass pollen season.
3.A clinical history of perennial allergic rhinitis and/or asthma having received regular medication due to an allergen to which the subject is regularly exposed
4.A clinical history of chronic sinusitis during the last 2 years
5.A clinical history of severe asthma (Step 4, according to GINA definition)
6.Any clinical relevant chronic disease
7.Current severe atopic dermatitis
8.Use of an investigational drug within 30 days prior to screening
9.Previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years
10.Use of any of the following drugs within the time indicated prior to randomisation or during the study period unless provided as rescue medication:

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy and safety of specific immunotherapy with Grazax compared to placebo, in children with grass pollen induced allergic rhinoconjunctivitis.;Primary end point(s): ;Secondary Objective: •To investigate the efficacy and safety of Grazax based on the following information:<br>?Rhinoconjunctivitis symptom and medication scores in the peak grass pollen season<br>?Asthma symptom and medication score in the grass pollen season<br>?Asthma symptom and medication score in the peak grass pollen season<br>?Pharmacoeconomic data in the grass pollen season<br>?Safety Assessments at screening and End of treatment<br>